PERANCANGAN ANALISIS RISIKO ISO 9001:2015 di PT. XYZ

Adi Cahyadi Dwi Putra Budiman(1*), Jani Rahardjo(2),


(1) 
(2) 
(*) Corresponding Author

Abstract


PT. XYZ is a manufacture company which specializes in producing Machine-Glazed paper. The purpose of this research is to design the analysis of risk and related documents in or­der to complete the requirements of Quality Management System ISO 9001: 2015 in PT. XYZ. Early quality review showed 59% suitability before risk analysis of quality management system ISO 9001: 2015 was implemented. Designing risk analysis of quality management system ISO 9001: 2015 uses Failure Mode and Effect Analysis (FMEA) method. This research is currently in designing phase and will be implemented in all departments of PT. XYZ, such as; HRD & GA, Production, Technical, Warehouse, PPC, Quality Control, Purchasing, Marketing, and Ship­ment. The result of risk analysis with FMEA method suggest that the biggest risks in PT. XYZ are bad paper quality, returned commodity from consumer, and shipment delay of finished goods. Designing quality management system ISO 9001: 2015 is equipped with commission of SOP, IK, SWOT analysis, Job Description, and Competency Matrix. The final quality assess­ment after designing quality management system shows 84% suitability with ISO 9001: 2015 requirements


Keywords


Quality Management System; ISO 9001: 2015

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References


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Stamatis, D. H., The ASQ Pocket Quide to Failure Mode and Effect Analysis (FMEA), ASQ Quality Press, Milwaukee, 2015.


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